US lost US$ 7.6 billion since 2015 due to patent walls that delayed biosimilars

By PharmaCompass

2019-07-04

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Two years ago, independent policy research group RAND Health had predicted that biosimilars would save the US roughly US$ 54 billion from 2017 through 2026. But today, that sounds like a distant dream.

The US sales of biosimilars have been so limited that their future seems uncertain. The US lags behind Europe in the number of biosimilars available — 19 biosimilars have been approved in the US, but only seven are available. In contrast, Europe has 54 biosimilars available today at discounts of up to 80 percent.

A report released last week by a biosimilars trade group estimated the US healthcare system lost US$ 7.6 billion in possible savings since 2015 due to patent walls delaying sales of approved biosimilars.

Biosimilars are near-copies of complex and expensive biologic drugs to treat cancer, rare diseases and autoimmune disorders like rheumatoid arthritis and colitis.

A decade ago, the US Congress passed a law meant to encourage development of cheaper biosimilars. But biologic drugmakers fought back to block them with successive patents, lawsuits and rebates to insurers.

Their tactics include disparaging biosimilars as inferior, luring patients with coupons subsidizing their copayments, getting successive patents to extend their monopolies, and giving rebates to insurance plans which cover their biologic drugs but exclude rival biosimilars.

In Europe, monopoly-protecting patents generally don’t last as long as in the US. In fact, government-run health systems favor biosimilars in Europe.

Given their limited sales, the FDA is trying to enable faster approval of biosimilars. In May, it issued guidelines to enable biosimilar-makers to show their products are interchangeable with an original biologic drug.

According to Scott Gottlieb, former commissioner of FDA, health plans are reluctant to take up biosimilars, because that would instantly end their big rebates.

Since biosimilars have made little impact till date, a few experts are calling for the US to abandon biosimilars altogether, and instead, regulate prices for biologic drugs. However, biosimilar companies like Samsung Bioepis think this is unwarranted.

“People are too impatient with the current launch status of biosimilars,” Christopher Ko, head of Samsung Bioepis said. “Market shaping takes time,” he added.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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